Vibration + Orthodontic Treatment for Dental Ankylosis

Overseen by Wei Huang, DDS, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Systemic medications

Disqualifiers: Severe ankylosis, Systemic disorders, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study is to determine whether one (or two) new method(s) will help treat dental ankylosis. This study tackles the challenging tooth-bone fusion disorder of ankylosis. In growing patients, ankylosis causes significant developmental bone defects due to its inhibition of the vertical growth of the affected alveolar bone area.

Will I have to stop taking my current medications?

The trial excludes participants who are taking any systemic medications, so you would need to stop taking them to participate.

What data supports the effectiveness of the treatment Vibration + Orthodontic Treatment for Dental Ankylosis?

Research shows that vibrating devices, including electric toothbrushes, can help speed up tooth movement and reduce pain during orthodontic treatment, which may suggest potential benefits for treating dental ankylosis. ^{1 2 3 4 5}

Is the use of vibrating toothbrushes and similar devices generally safe for humans?

Research indicates that electric toothbrushes with vibrational frequencies of 125-150 Hz are safe for teeth and supporting structures, and there is no difference in safety between oscillating-rotating powered brushes and manual toothbrushes. ^{1 6 7 8 9}

How is the Vibration + Orthodontic Treatment for Dental Ankylosis different from other treatments?

This treatment is unique because it combines vibrations from an electric toothbrush with mini-implant-assisted orthodontic treatment to potentially speed up tooth movement and reduce discomfort, which is not a standard approach for dental ankylosis. ^{1 2 3 5 10}

Research Team

Wei Huang, DDS, PhD

Principal Investigator

Rutgers School of Dental Medicine

Eligibility Criteria

This trial is for individuals aged 6-30 with a clinical diagnosis of dental ankylosis, which includes a history of dental trauma, infra-eruption without obstruction, and specific X-ray or CBCT imaging signs. Participants must be English-speaking and able to follow the study's requirements. Pregnant individuals, those not fluent in English, with severe tooth ankylosis, mental disorders affecting compliance, allergies to local anesthesia used here, systemic health issues (affecting bleeding/skeletal health), or who are currently infectious are excluded.

Inclusion Criteria

I have a tooth that doesn't move and is partly visible in my mouth.

I am between the ages of 6 and 30.

Full informed consent and/or informed assent (minors)

Exclusion Criteria

Has a history of smoking

Any mental or developmental disorders that affect patient understanding or compliance

Allergic to our local anesthetic drug

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vibration Treatment

Participants use an electric toothbrush handle to vibrate the ankylosed tooth for 15-60 seconds every day for five days

1 week

1 visit (in-person) at the start, follow-up visits as needed

Mini-implant Treatment

For permanent teeth where vibration treatment fails, a mini-implant is placed for orthodontic treatment

6 weeks

Monthly follow-up visits for up to five months

Follow-up

Participants are monitored for changes in ankylosed tooth position and alveolar bone defect level

9 months

Regular follow-up visits as per outcome measure timeframes

Treatment Details

Interventions

• Electric Toothbrush-Generated Vibration (Procedure)
• Mini-Implant-Assisted Orthodontic Treatment (Procedure)

Trial Overview The study tests two new treatments for dental ankylosis: vibrations from electric toothbrushes and mini-implant-assisted orthodontic treatment. The goal is to see if these methods can address the issue where teeth fuse to bone and disrupt normal growth in affected areas.

Participant Groups

Group I: Vibration and Mini-implant Group Experimental Treatment 2 Interventions

For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.

Group II: Vibration Group Experimental Treatment 1 Intervention

For primary and permanent teeth that will receive only toothbrush vibration treatment.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

A systematic review of seven studies involving 105 patients using vibrating devices for orthodontic treatment found no significant difference in tooth movement compared to a control group.

The analysis indicates that vibrating devices do not effectively accelerate orthodontic tooth movement, suggesting they may not be a beneficial addition to orthodontic treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of using a Vibrating Device in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. Elmotaleb, MAA., Elnamrawy, MM., Sharaby, F., et al.[2022]

In a study involving 45 orthodontic patients, low-frequency vibrations used with aligners improved the accuracy of upper incisor rotation compared to a conventional aligner protocol without vibrations.

Replacing aligners every 7 days with low-frequency vibrations did not show significant differences in accuracy compared to replacing them every 14 days, indicating that the vibration protocol can enhance treatment without needing to change the replacement frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial. Lombardo, L., Arreghini, A., Huanca Ghislanzoni, LT., et al.[2020]

A systematic review of 6 randomized controlled trials found that vibrational devices generally do not significantly increase the rate of orthodontic tooth movement, with only 1 out of 5 studies showing any benefit.

Additionally, the review indicated that vibrational devices do not effectively reduce pain associated with orthodontic treatment, as 3 studies reported no significant effect on pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrational devices on orthodontic tooth movement: A systematic review. Aljabaa, A., Almoammar, K., Aldrees, A., et al.[2018]

In a case series involving five orthodontic patients aged 9 to 22, the Oral-B iO oscillating-rotating electric toothbrush with the Targeted Clean brush head significantly reduced plaque accumulation by 15% to 45% over a 9 to 14-week period.

Patients reported increased motivation to brush their teeth, and both patients and caregivers expressed satisfaction with the toothbrush, indicating its effectiveness and acceptability for improving oral hygiene in orthodontic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Oscillating-Rotating Electric Toothbrush and Novel Brush Head to Increase Brushing Motivation and Reduce Plaque Among Orthodontic Patients. Van Elslande, D.[2022]

In a study involving 23 orthodontic patients, the use of a battery-powered toothbrush to apply vibratory stimulus during canine retraction did not significantly accelerate tooth movement compared to the control side (P = 0.70).

The study lasted for an average of 3 months and involved the use of miniscrews and nickel-titanium springs, but ultimately found that the vibratory stimulus had no beneficial effect on the speed of orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and importance of powered tooth brushes in tooth movement. Kannan, S., Fassul, S., Singh, AK., et al.[2022]

Using an electric toothbrush with a vibration frequency of 150 Hz significantly increased the rate of orthodontic tooth movement (OTM) and levels of prostaglandin E2 (PGE2) compared to a 125 Hz toothbrush and a control group without an electric toothbrush.

The study involved 30 patients aged 18-25, and the results showed that mechanical vibration from the toothbrushes enhanced PGE2 production, which is linked to accelerated tooth movement during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 125 Hz and 150 Hz vibrational frequency electric toothbrushes on the rate of orthodontic tooth movement and prostaglandin E2 levels. Gujar, AN., Shivamurthy, PG.[2023]

The systematic review found that oscillating-rotating powered brushes are generally safe for both soft and hard tissues in the mouth when compared to manual toothbrushes, indicating they can be a reliable option for oral hygiene.

This review is based on high-quality evidence, providing strong recommendations for the use of powered brushes, supported by funding from a reputable industry source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is no difference with regard to hard and/or soft tissue safety between oscillating-rotating powered brushes and manual toothbrushes. Farsi, NJ., Nicolau, B.[2013]

A finite element method study found that using an electric toothbrush with a vibrational frequency of 125-150 Hz applied a force of 15 g, resulting in negligible stress and deflection on teeth and jaw structures, indicating safety for dental health.

The study concluded that this range of vibrational frequency is optimal for electric toothbrushes, as it does not produce harmful effects on the maxilla, mandible, or dentition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 125-150 Hz Vibrational Frequency Electric Toothbrush on Teeth and Supporting Structures: A Finite Element Method Study. Gujar, AN., Shivamurthy, PG., Sabrish, S.[2022]

In a randomized clinical trial involving 27 adult patients undergoing Invisalign treatment, the AcceleDent Aura device showed no significant impact on the completion rates of aligners or the final alignment achieved, indicating it may not enhance orthodontic outcomes.

The study also found no significant differences in pain levels, aligner compliance, or quality of life between the group using the AcceleDent device and the sham group, suggesting that the device does not provide additional benefits during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of supplemental vibration on orthodontic treatment with aligners: A randomized trial. Katchooi, M., Cohanim, B., Tai, S., et al.[2018]

References

1. India pubmed.ncbi.nlm.nih.gov

Effectiveness of using a Vibrating Device in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of vibrational devices on orthodontic tooth movement: A systematic review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Use of an Oscillating-Rotating Electric Toothbrush and Novel Brush Head to Increase Brushing Motivation and Reduce Plaque Among Orthodontic Patients. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Effectiveness and importance of powered tooth brushes in tooth movement. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of 125 Hz and 150 Hz vibrational frequency electric toothbrushes on the rate of orthodontic tooth movement and prostaglandin E2 levels. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

There is no difference with regard to hard and/or soft tissue safety between oscillating-rotating powered brushes and manual toothbrushes. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Insufficient Evidence within a Systematic Review and Meta-Analysis of Powered Toothbrushes over Manual Toothbrushes for Soft Tissue Health During Orthodontic Treatment. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Effect of 125-150 Hz Vibrational Frequency Electric Toothbrush on Teeth and Supporting Structures: A Finite Element Method Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of supplemental vibration on orthodontic treatment with aligners: A randomized trial. [2018]